Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)

Subjects with atopic dermatitis (AD) will be treated with either tralokinumab or dummy
treatment (placebo) for 16 weeks. All subjects will receive 2 vaccines at Week 12. The
vaccines are:

1. Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis
(whooping cough) vaccine. This combination vaccine is also known as the Tdap vaccine and
is used to prevent these 3 diseases.

2. Meningococcal vaccine. This vaccine is used to prevent meningococcal diseases (infection
of the brain and spinal cord) and blood poisoning.

The primary objective of the trial is to demonstrate non-inferiority of tralokinumab versus
placebo with respect to immune responses to concomitantly administered vaccines.

The secondary objective is to evaluate efficacy of tralokinumab concomitantly administered
with vaccines.

Inclusion Criteria:

- Age 18 to 54 years

- Diagnosis of AD as defined by Hanifin and Rajka (1980) criteria for AD

- History of AD for ≥1 year

- Subjects who have a recent history of inadequate response to treatment with topical
medications or for whom topical treatments are otherwise medically inadvisable

- AD involvement of ≥10% body surface area at screening and baseline

- An EASI score of ≥12 at screening and 16 at baseline

- An IGA score of ≥3 at screening and at baseline

- Subjects must have applied a stable dose of emollient twice daily (or more, as needed)
for at least 14 days before randomisation

Exclusion Criteria:

- Subjects for whom administration of the meningococcal vaccine provided in this trial
is contraindicated or medically inadvisable, according to local label of the vaccine

- Subjects for whom administration of the tetanus, diphtheria, and pertussis vaccine
provided in this trial is contraindicated or medically inadvisable, according to local
label of the vaccine

- Active dermatologic conditions that may confound the diagnosis of AD or would
interfere with assessment of treatment

- Use of tanning beds or phototherapy within 6 weeks prior to randomisation

- Treatment with systemic immunosuppressive/immunomodulating medications and/or systemic
corticosteroids within 4 weeks prior to randomisation

- Treatment with the topical medications topical corticosteroids (TCS), topical
calcineurin inhibitor (TCI) or phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks
prior to randomisation

- Receipt of any vaccine (except influenza virus vaccines) within 3 months prior to
screening, any meningococcal vaccine within 1 year prior to screening, or any
tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to
screening

- Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic
agent, including dupilumab

- History of any active skin infection within 1 week prior to randomisation

- History of a clinically significant infection (systemic infection or serious skin
infection requiring parenteral treatment) within 4 weeks prior to randomisation